WHO prequalifies Jynneos mpox vaccine, releases countermeasure allocation plan

Jynneos

Photo: Courtesy of Bavarian Nordic

The World Health Organization (WHO) today announced that it has prequalified Bavarian Nordic's mpox vaccine (Jynneos), which paves the way for wider use in Africa's widening mpox outbreak.

Also today, the agency unveiled a mechanism for allocating vaccines and treatments among the outbreak countries. That group now include Morocco, which reported its first case, making it the first affected country this year in North Africa.

Prequalification eases vaccine access

The Bavarian Nordic vaccine is the first mpox vaccine to receive prequalification, which paves the way for groups such as Gavi, the Vaccine Alliance, and UNICEF to buy doses for lower-income countries. It is called Imvamune in Canada and Imvanex in Europe.

In a statement, WHO Director-General Tedros Adhanom Ghebreyesus, PhD, said prequalification is an important step in the fight against mpox. "We now need urgent scale up in procurement, donations and rollout to ensure equitable access to vaccines where they are needed most, alongside other public health tools, to prevent infections, stop transmission and save lives," he said.

The WHO said the vaccine may be given to people 18 years and older as a two-dose series given 4 weeks apart. It added, however, that the vaccine can be given "off label" in infants, children, adolescents, pregnant women, and those with underlying medical conditions if the benefits outweigh the risks. 

The WHO is also discussing prequalification and emergency use listing with the makers of two other mpox vaccines, LC-16, from KM Biologics in Japan, and ACAM2000, from Emergent BioSolutions.

In a related development, the WHO announced an access and allocation tool for mpox countermeasures, which it established with input from member states and partner groups. So far, countries have pledged 3.6 million doses of mpox vaccine for Africa's response, which includes 620,000 doses of Jynneos from the United States, Europe, and Bavarian Nordic, and 3 million doses of LC-16 from Japan.

Officials from the Africa Centres for Disease Control and Prevention (Africa CDC) have estimated that 10 million doses are needed.

Africa's outbreak intensifies; in utero transmission reported

Africa's mpox outbreaks continue to grow, with 3,160 cases reported over the past week, 434 of them confirmed, and 107 more deaths from the virus, Jean Kaseya, MD, MPH, head of Africa CDC, said at a briefing yesterday.

Since the first of the year, 26,543 cases, 724 of them fatal, have been reported across 14 countries, with the Democratic Republic of the Congo (DRC) the main hot spot, but with steady rises occurring in other areas, such as Burundi. Kaseya said children continue to make up the largest portion of cases, and 41% of all infections are in kids younger than 15, a trend he said is also seen in Burundi and the Central African Republic.

Surveillance has improved, and the case-fatality rate has declined, with earlier detection of mpox illnesses, Kaseya said. However, he said health officials are still trying to better understand the epidemiology of the virus. 

In utero transmission is occurring, leading to infections in newborns, Kaseya added, though he said Africa CDC officials don't have solid case numbers.

First case of the year in North Africa

In a breaking development, Africa CDC today said Morocco has reported its first mpox case of 2024, marking the first case of the year to be reported in North Africa, which means the virus has spread to all five African regions.

In a statement, the agency said the patient is a 32-year-old man from Marrakech who is being treated in isolation. Moroccan officials have activated emergency operations, deployed a rapid response team, and have launched an epidemiologic investigation and contact tracing. 

So far, the clade isn't known. The outbreaks in Africa are complex, with multiple clades circulating in the DRC, including novel clade 1b. Some of the DRC's neighboring countries have reported clade 1b, while other countries are seeing other clades, including the global clade 2 virus.

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